A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

Sponsor

Tocagen Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04327011

Collaborator

(none)

Enrollment

Locations

Arm

106

Actual Duration (Months)

5.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care.

If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients.

Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals.

After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years.

All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme Astrocytoma Gliomas, Malignant	Biological: Toca 511 vector Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

Actual Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Single arm Toca 511 vector/5-FC prodrug	Biological: Toca 511 vector Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector Other Names: vocimagene amiretrorepvec RRV retroviral replicating virus Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine Toca FC is an extended-release formulation of flucytosine. Other Names: Extended Release 5-FC 5-FC 5-Fluorocytosine

Arm

Intervention/Treatment

Experimental: Experimental

Single arm Toca 511 vector/5-FC prodrug

Biological: Toca 511 vector

Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector

Other Names:

vocimagene amiretrorepvec

RRV

retroviral replicating virus

Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine

Toca FC is an extended-release formulation of flucytosine.

Other Names:

Extended Release 5-FC

5-FC

5-Fluorocytosine

Outcome Measures

Primary Outcome Measures

Long term safety follow up [From study entry up to 15 years]
This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.

Secondary Outcome Measures

Overall survival in days from the initial Toca 511 administration on parent study to the date of death. [From initial Toca 511 administration to death of last patient alive for up to 15 years.]

Other Outcome Measures

Progression-free survival in days from the initial Toca 511 administration on parent study to confirmed disease progression or death from any cause. [from initial toca 511 administration to time of progression or death of any cause for up to 15 years.]
Objective response rate from initial dose of Toca FC from the parent protocol [Time from initial dose of Toca FC to death of last patient alive for up to 15 years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Informed Consent Form
Subject received Toca 511 in prior study.
Subject is willing to abide by protocol

Exclusion Criteria:

Subject has history of allergy or intolerance to flucytosine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	UCSD	San Diego	California	United States	92093
3	UCSF	San Francisco	California	United States	94143
4	Henry Ford Health System	Detroit	Michigan	United States	48202
5	JFK Medical Center Neuroscience Institute	Edison	New Jersey	United States	08820
6	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
7	John Theurer Cancer Center at Hackensack University	Hackensack	New Jersey	United States	07601
8	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
9	Ohio State University	Columbus	Ohio	United States	43210
10	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232
11	Swedish Neuroscience Institute	Seattle	Washington	United States	98122